Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)

NCT05579366 | Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: GCT1184-01CTR20230813jRCT2051250094PRO1184-001
• Study Type: interventional
• Target: 884
• Locations: 3 countries
• Sites: 66

Brief Summary

This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

Conditions

High Grade Serous Ovarian Cancer; Primary Peritoneal Carcinoma; High Grade Epithelial Ovarian Cancer; Non-small Cell Lung Cancer; Fallopian Tube Cancer; Endometrial Cancer; Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC); Mesothelioma; Breast Adenocarcinoma; Triple Negative Breast Cancer; Hormone Receptor-positive/Her2 Negative Breast Cancer; Platinum-resistant Ovarian Cancer (PROC); Platinum Sensitive Ovarian Cancer (PSOC); Primary Refractory Ovarian Cancer; Uterine Cancer

Keywords

antibody-drug conjugate; folate receptor alpha; folate receptor; solid tumor; ovarian cancer; primary peritoneal carcinoma; fallopian tube cancer; endometrial cancer; non-small cell lung cancer; mesothelioma; breast cancer; triple negative breast cancer; hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer; topoisomerase I inhibitor; PROC; epidermal growth factor receptor (EGFR)-mutated NSCLC

Outcome Measures

Primary Outcomes (4)

• Parts A, B, and D - Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]

  Through end of treatment, up to approximately 1 year.

• Parts A, and D - Dose Limiting Toxicity (DLT)

  The proportion of participants experiencing DLT.

  At the end of Cycle 1 (each cycle is 21 days)

• Parts C, E, F, G, H, I, and J- Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR, Parts C and F) or Investigator (Part E, G, I, and J) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria.

  Through end of treatment, up to approximately 1 year.

• Part K (US Participants Only) - Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Findings by Holter

  Cycles 1 to 3 (each cycle is 21 days)

Secondary Outcomes (14)

• Parts A, B, and D - Best Overall Response (BOR)

  Up to approximately 1 year.

• Parts A, B, D, and E - ORR

  Up to approximately 1 year.

• Parts A, B, and D - Disease Control Rate (DCR)

  Up to approximately 1 year.

• Parts A, B, C, D, E, F, G, H, I, and J - Progression-Free Survival (PFS)

  Through end of treatment, up to approximately 1 year.

• Parts C, E, F, G, H, I and J - Overall survival (OS)

  Up to approximately 2 years.

Study Arms (4)

Part A, B, C, E, F, G, H, I, J and K

EXPERIMENTAL

Rina-S monotherapy in Part A and at the recommended dose in Parts B, C, E, F, G, H, I, J and K.

Drug: Rina-S

Part D1

EXPERIMENTAL

Rina-S in combination with carboplatin

Drug: Rina-S; Drug: Carboplatin

Part D2 and I

EXPERIMENTAL

Rina-S in combination with bevacizumab

Drug: Rina-S; Drug: Bevacizumab

Part D3 and D4

EXPERIMENTAL

Rina-S in combination with pembrolizumab

Drug: Rina-S; Drug: Pembrolizumab

Interventions

Rina-S DRUG

Intravenous infusion of Rina-S

Also known as: PRO1184, Rinatabart sesutecan, GEN1184

Part A, B, C, E, F, G, H, I, J and K; Part D1; Part D2 and I; Part D3 and D4

Carboplatin DRUG

Carboplatin intravenous infusion

Part D1

Bevacizumab DRUG

Bevacizumab intravenous infusion

Part D2 and I

Pembrolizumab DRUG

Pembrolizumab intravenous infusion

Part D3 and D4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part A and B:
• Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptor positive, HER2-negative and triple-negative) (Part A), mesothelioma or cervical cancer (Part B).
• Previously received therapies known to confer clinical benefit.
• Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline.
• Part C, E, and H:
• Participants must have histologically or cytologically confirmed metastatic or unresectable epithelial ovarian cancer as specified below.
• High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, and those with a sarcomatous or neuroendocrine element)
• Participants must have received up to 3 prior lines of therapy. Participants may have had up to to 4 prior lines of therapy are allowed if MIRV is locally approved and was used as the last line of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.
• Participants must have platinum-resistant ovarian cancer.
• Participants must have received prior bevacizumab or approved biosimilar.
• Participants with known or suspected deleterious germline or somatic BRCA mutations (as determined by Food and Drug Administration \[FDA\]-approved test in a Clinical Laboratory Improvement Amendments \[CLIA\]-certified laboratory; or locally approved equivalent) and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment.
• Measurable disease per the RECIST v1.1 at baseline.
• Part D:
• Cohort D1:
• Participants must have platinum-sensitive ovarian cancer.

You may not qualify if:

• History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids within the past 2 years, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
• Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.

Sponsors & Collaborators

• Genmab: lead

Study Sites (66)

USOR HonorHealth

Phoenix, Arizona, 85016, United States

RECRUITING

USOR Arizona Oncology Associates

Tucson, Arizona, 85711, United States

RECRUITING

University of California Los Angeles Medical Center

Los Angeles, California, 90095, United States

RECRUITING

University of California, San Diego; Moores Cancer Center

San Diego, California, 92093, United States

RECRUITING

USOR Sansum Clinic

Santa Barbara, California, 93105, United States

RECRUITING

Providence Medical Foundation

Santa Rosa, California, 95403, United States

RECRUITING

USOR Florida Cancer Specialists South

Fort Myers, Florida, 33908, United States

RECRUITING

USOR Florida Cancer Specialists North

St. Petersburg, Florida, 33709, United States

RECRUITING

USOR Florida Cancer Specialists East

West Palm Beach, Florida, 33401, United States

RECRUITING

Augusta University Georgia Cancer Center

Augusta, Georgia, 30912, United States

RECRUITING

University of Kansas Medical Center (KUMC)

Westwood, Kansas, 66205, United States

RECRUITING

USOR Maryland Oncology Hematology

Rockville, Maryland, 20850, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48085, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49503, United States

RECRUITING

USOR Minnesota Oncology Hematology

Maplewood, Minnesota, 55109, United States

RECRUITING

MD Anderson Cancer Center at Cooper- Two Cooper Plaza

Camden, New Jersey, 08103, United States

RECRUITING

Ohio State University Comprehensive Cancer Center (OSUCCC)- The James Cancer Hospital and Solove Research Institute

Columbus, Ohio, 43210, United States

RECRUITING

University of Oklahoma - Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

USOR Oncology Associates of Oregon, P.C.

Eugene, Oregon, 97401, United States

RECRUITING

Compass Oncology - Rose Quarter

Portland, Oregon, 97227, United States

RECRUITING

USOR Alliance Cancer Specialist

Doylestown, Pennsylvania, 18901, United States

RECRUITING

Allegheny Health Network

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

RECRUITING

Sarah Cannon Research Institute at Tennessee Oncology

Nashville, Tennessee, 37203, United States

RECRUITING

Tennessee Oncology

Nashville, Tennessee, 37203, United States

RECRUITING

USOR Texas Oncology

Abilene, Texas, 79606, United States

RECRUITING

Texas Oncology - Central / South Texas

Austin, Texas, 78758, United States

RECRUITING

Mary Crowley Cancer Research

Dallas, Texas, 75521, United States

RECRUITING

USOR Texas Oncology

Fort Worth, Texas, 76104, United States

RECRUITING

Texas Oncology - Northeast TX

Tyler, Texas, 75702, United States

RECRUITING

USOR Texas Oncology Gulf Coast

Woodland, Texas, 77380, United States

RECRUITING

START Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

USOR Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

RECRUITING

USOR Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

RECRUITING

Swedish Cancer Institute

Seattle, Washington, 98104, United States

RECRUITING

Cancer hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

Hunan Cancer Hospital - Phase 1

Changsha, Hunan, China

RECRUITING

Hunan Cancer Hospital - Thoracic Medicine Dept II

Changsha, Hunan, China

RECRUITING

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, China

RECRUITING

Jilin Cancer Hospital

Changchun, Jilin, China

RECRUITING

Obstetrics & Gynecology Hospital of Fudan University

Chengdu, Shanghai Municipality, China

RECRUITING

Fudan University Shanghai Cancer Center - Gynecologic Oncology

Shanghai, Shanghai Municipality, China

RECRUITING

Fudan University Shanghai Cancer Center- Phase 1

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Sichuan Cancer Hospital

Shanghai, Sichuan, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

Fujian Cancer Hospital

Fujian, China

RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangdong, China

RECRUITING

Second Affiliated Hospital of Zhengzhou University

Henan, China

RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Hubei, China

RECRUITING

Second Hospital of Shanxi Medical University

Shanxi, China

RECRUITING

Shanxi Cancer Hospital

Shanxi, China

RECRUITING

Liaoning Cancer Hospital & Institute

Shengyang, China

RECRUITING

Tianjin Cancer Hospital

Tianjin, China

RECRUITING

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

RECRUITING

Gunma Prefectural Cancer Center

Ōta, Gunma, Japan

RECRUITING

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

RECRUITING

Hyogo Cancer Center

Akashi, Hyōgo, Japan

RECRUITING

Saitama Medical University-International Medical Center

Hidaka, Saitama, Japan

RECRUITING

Shizuoka Cancer Center

Nagaizumi-chō, Shizuoka, Japan

RECRUITING

Cancer Institute Hospital of JFCR

Koto, Tokyo, Japan

RECRUITING

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

RECRUITING

Yamagata University Hospital

Yamagata, Yamagata, Japan

RECRUITING

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Endometrial Neoplasms; Carcinoma, Non-Small-Cell Lung; Mesothelioma; Triple Negative Breast Neoplasms; Uterine Neoplasms; Ovarian Neoplasms; Breast Neoplasms

Interventions

Carboplatin; Bevacizumab; pembrolizumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Study Official

  Genmab

  STUDY DIRECTOR

Central Study Contacts

Genmab Trial Information

CONTACT

+4570202728; clinicaltrials@genmab.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 13, 2022
• Study Start: December 7, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (9); US (37); CN (20)